ClinicReady Case Study
Our agile approach to drug development challenges
“The Avance team demonstrated flexibility and a solution-oriented attitude in working with us towards obtaining rapid ethics approval, thereby facilitating trial initiation in a timely and efficient manner.”Dr. Russell Rother, President and Chief Operating OfficerTetherex Pharmaceuticals
Tetherex Pharmaceuticals: An example of using an agile approach in study design to achieve the best outcome for clients.
Tetherex Pharmaceuticals is developing a single-cycle adenoviral vector vaccine for the treatment of COVID-19. The treatment is designed for intranasal delivery which is expected to provide a more efficient front-line defense against COVID-19 in airway tissues, the site of virus entry into the body. The vaccine is currently undergoing safety testing in healthy volunteers.
Tetherex developed a protocol which included both intranasal and intramuscular administration of the vaccine. Since adenovirus vectors are considered genetically modified organisms (GMOs), the vaccine required a special license from the Office of Gene Technology Regulator (OGTR). This license provides a set of guidelines to minimize accidental release of the virus into the environment. Through interactions with the OGTR, it was determined that adenovirus-based vaccines administered via the intramuscular route require a Dealings not Involving an Intentional Release (DNIR) license through OGTR while vaccines administered via the intranasal route require a Dealings Involving Intentional Release (DIR) license. Obtaining a DNIR license requires 90 days while a DIR license can take up to 150 days. The timing of the DIR license created a significant delay in starting a trial which is seeking to accrue participants against the background of approved vaccine rollout in Australia. A strategy needed to be devised to allow for earlier start-up for this study.
The Avance ClinicReady team was able to work with the client in amending the protocol design to only include intramuscular administration in the first instance following granting of the DNIR licence which allowed for earlier HREC approval and study start-up. The protocol was subsequently amended to include the intranasal administration and approval of the DIR licence shortly followed. This adaptable, staggered approach offered by ClinicReady allowed this study to rapidly proceed into the clinic.